Pharmacotherapy for acute and chronic insomnia may be necessary for severe or resistant cases of insomnia. The decision to prescribe should be on an individual basis and involve serious consideration of all risks and possible benefits.

Benzodiazepines and Z drugs have been shown to be effective treatments and may be prescribed for short-term or intermittent use. Harm, such as dependence and adverse events, may occur with both drug groups.

Dose reduction and cessation should be discussed with the patient on first prescription and commenced once sleep patterns return to normal.

Pharmacological treatment should be accompanied by specific patient education and regular review.

Evidence statements

Grade

Rec 1

Cognitive behavioural therapy (CBT) based treatment packages for chronic insomnia, including sleep restriction and stimulus control, are effective and therefore should be offered to patients as first-line treatment.101

A

Rec 2

Z drugs and short-acting benzodiazepines are efficacious for insomnia.101

A

Rec 3

Prescription of zolpidem and zopiclone should be treated with the same caution as benzodiazepines.102

A

Rec 4

Intermittent dosing may reduce the risk of tolerance and dependence.101

B

Rec 5

If hypnotics are to be used for treating insomnia, it is recommended that treatment is short term (not more than 4 weeks) and at the lowest possible dose.103

B

2.2.1 Background

Sleep disturbance is the third most common psychological reason for patient encounters in general practice. Population surveys found 13–33% of adult Australians have regular difficulties getting to sleep or staying asleep.104

Insomnia is defined in DSM-5 as a difficulty in getting to sleep, staying asleep or having non-restorative sleep despite having adequate opportunity for sleep, together with associated impairment of daytime functioning, with symptoms being present for at least 4 weeks.40

Acute insomnia meets the DSM-5 definition of insomnia, but with symptoms occurring for less than 4 weeks.40 It is experienced by up to 80% of the population at some stage, generally due to one or more precipitating factors.105

Provided patients adhere to good sleep habits, most will return to normal sleep once the precipitating factor has resolved or diminished.106

Chronic insomnia was previously viewed as a sleep disturbance that was secondary to a medical condition, psychiatric illness, sleep disorder or medication, and would improve with treatment of the underlying disorder.107,108 However, evidence over the last 20 years indicates this view is incorrect. It is now recognised that insomnia may be an independent disorder.108–110 The understanding of chronic insomnia continues to evolve. Insomnia may have some similarities with depression in that they both represent long-term disorders for which many patients require maintenance treatment.

Chronic insomnia may occur in the absence of coexisting conditions. When coexisting conditions exist, insomnia may persist despite successful treatment of the coexisting condition. Treatment directed at the insomnia, rather than the comorbidity, may be necessary. Since insomnia can precipitate, exacerbate or prolong comorbid conditions, treatment of insomnia may in turn improve comorbidities.

2.2.2 Management of insomnia in general practice

When patients present with insomnia to GPs in Australia, few (0.8%) receive a referral for specific non-drug therapy.112 All guidelines strongly recommend psychological and behavioural management.68,102,108,113

determining the effects of poor sleep on the patient (eg poor memory, fatigue, work absence, accidents)

identifying comorbid conditions – this may be aided by the Auckland Sleep Questionnaire, which is a validated screening tool.114

2.2.2.2 Acute insomnia

Treatment is focused on avoiding or withdrawing the precipitant, if possible. All patients should receive basic behavioural counselling on sleep hygiene and stimulus control.

Drug treatment may be indicated as an adjuvant to non-drug therapies for acute insomnia that is severe, disabling and causing distress. Benzodiazepines and Z drugs are the most effective drugs.25 The short-term use of benzodiazepines as hypnotic agents should only be one aspect of general management,25 with a clear endpoint of drug cessation once sleep patterns return to normal.

2.2.2.3 Chronic insomnia

Management of chronic insomnia starts with addressing any relevant, underlying problems that are present, such as:

Psychological and behavioural treatments administered weekly over a 4–8– week period have shown robust and stable improvements in sleep continuity for up to 2 years.123 These therapies are now available online, which has vastly improved access.

Refer to Resource G for a GP guide to behavioural therapies for insomnia.

2.2.2.5 Drug therapy

For patients who continue to have insomnia that is sufficiently burdensome to warrant other interventions, reasonable approaches include continued behavioural therapies, medication or both.108

Recommendations in guideline on the use of medication for chronic insomnia vary. This is primarily due to the lack of evidence from extended trials that adequately compare long-term risks and harms of these medications. Some guidelines suggest avoidance of hypnotic drugs as far as possible,102 while others make a considered judgement on the risks and benefits.68,108,113

The decision to treat chronic insomnia must weigh any potential serious side effects associated with pharmacologic therapy against potential health risks of not providing treatment. This includes decreased quality of life, increased risk for psychiatric comorbidities and SUD, and decreased performance. The approach should be individualised according to the patient’s values and preferences, the availability of advanced behavioural therapies, the severity and impact of the insomnia, and the potential benefits versus the risks, costs and inconveniences.108

Pharmacological treatment should be accompanied by specific patient education, regular review and continued effort to employ the lowest effective maintenance dosage of medication, and to taper medication when conditions allow.113

Benzodiazepines – May have a place in the treatment of severe acute insomnia or treatment-resistant chronic insomnia. For patients with sleep onset insomnia, a short-acting medication is a reasonable choice for an initial trial of pharmacologic therapy. This may improve the insomnia with less residual somnolence the following morning. For patients with sleep maintenance insomnia, a longer-acting medication is preferable for an initial trial of pharmacological therapy.108

Z drugs – Have been shown to be effective in the treatment of insomnia in the short term. However, there is very limited evidence that they retain their efficacy during long-term treatment.123 Z drugs are associated with issues relating to adverse events, rebound insomnia, development of tolerance and SUD, and need to be carefully monitored in individual patients.123 Zolpidem’s black box warning states, ‘Zolpidem may be associated with potentially dangerous complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. Zolpidem is not to be taken with alcohol. Caution is needed with other CNS depressant drugs. Limit use to four weeks maximum under close medical supervision’.124
Psychological and behavioural treatments produce comparable outcomes to Z drugs during active treatment and have better durability beyond the active administration of treatment.123
Prescription of zolpidem and zopiclone should be treated with the same precautions and patient management as benzodiazepines.102

Melatonin – An endogenous hormone associated with the control of circadian rhythms and sleep regulation. Melatonin levels may be reduced in middle-aged and elderly patients with insomnia. Supplementation with melatonin has been shown to improve limited aspects of sleep in 30–50% of patients over 55 years of age.106,125,126 Data from clinical trials are variable. Some showed that some patients gain clinically significant improvements in quality of sleep and morning alertness with prolonged-release melatonin, but many patients in the clinical trials did not respond to treatment.35 Melatonin does not appear to be addictive or cause withdrawal effects when stopped.125 There are a lack of long-term study data.

At the time of writing, melatonin is available in Australia as a prolonged-release formulation for short-term treatment of primary insomnia, characterised by poor sleep quality in patients aged 55 years or older.35 The recommended dose is 2 mg orally at bedtime, and at present, there is insufficient evidence to support treatment beyond 3 weeks.35
In a European campaign to reduce benzodiazepine and Z drug usage, the availability of prolonged-release melatonin was shown to positively contribute to success.127

Other prescription medications – Includes antipsychotics (eg quetiapine, olanzepine). Studies demonstrating the usefulness of these medications for either short- or long-term management of insomnia are lacking. Furthermore, these agents have significant risks and therefore, their use in the treatment of chronic insomnia (without a relevant comorbid condition) cannot be recommended.107 Numerous other medications have a sedating effect, but are not recommended for routine use in patients with insomnia. These include antidepressants, diphenhydramine and antipsychotics.108

Over-the-counter (OTC) medications – Such as antihistamines or antihistamine/analgesic type drugs, and herbal and nutritional substances (eg valerian) are not recommended in the treatment of chronic insomnia due to the relative lack of efficacy and safety data.

Psychotropic Drugs Committee. Practice Guideline 5: Guidelines for use of benzodiazepines in psychiatric practice: Royal Australian and New Zealand College of Psychiatrists. Melbourne 2008 (update, first issued 1991).

Guideline Working Group for the Treatment of Patients with Insomnia in Primary Care. Clinical Practice Guidelines for the Management of Patients with Insomnia in Primary Care. UETS No 2007/5–1. Madrid: Ministry of Health and Social Policy. Health Technology Assessment Unit; 2009.

National Institutes of Health. National Institutes of Health State of the Science Conference statement on Manifestations and Management of Chronic Insomnia in Adults, June 13–15, 2005. Sleep 2005;28(9):1049–57.